Colorectal CancerNCT01470586
Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer
A study testing Surgery for colorectal cancer in people with Colorectal Cancer and Colon Rectal Resection, run by G. Hatzikosta General Hospital at 1 site in Greece.
Trial summary
Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for RNA peroxidation)in patients with colorectal cancer undergo surgical treatment (preoperatively during the intervention and… Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colon Rectal Resection, Oxidative Stress
- What is being tested?
- Surgery for colorectal cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- May 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with colorectal cancer
- Controls
Who cannot join
- ASA>3
- Metastatic Disease
- Acute bowel obstruction
- Acute bowel perforation
- BMI<30
- Chronic Systemic or Autoimmune Diseases
- Smokers
- Alcohol consumers
Trial locations and contacts
1 site in 1 country.
About this study
Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for RNA peroxidation)in patients with colorectal cancer undergo surgical treatment (preoperatively during the intervention and postoperatively) and controls.
Read the detailed description
Study of the impact of surgery on Lipid peroxidation, Protein peroxidation, damage by nitrogens, and RNA peroxidation, in patients undergo surgical resection for colorectal cancer and compared with controls, and validation of the responsiveness of oxidative stress markers on surgery
- Conditions
- Colorectal Cancer, Colon Rectal Resection, Oxidative Stress
- Being tested
- Surgery for colorectal cancer
- Keywords
- Colorectal cancer, Surgical resection, Oxidative Stress Markers, Controls
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for colorectal cancerProcedure or surgery
Also called Open or Laparoscopic resection for colorectal cancer, Low anterior resection, Sigmoidectomy, Left colectomy
Surgical resection of colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Surgery for colorectal cancer | Other | Colorectal cancer patients Receives: Procedure: Surgery for colorectal cancer |
| Controls | No intervention | Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Oxidative stress markers in patients with colorectal cancer and controls
Oxidative stress markers variation (8-PGF2α, Protein Carboyls, 3-Nitrotyrosine, 8-OHG) during and after surgery for colorectal cancer, and compare with controls
Measured: up to 2 years
Secondary outcomes (1)
Validation of oxidative stress markers in patients with colorectal cancer undergo surgical resection
Validation of the responsiveness of markers of oxidative stress 8-PGF2α, Protein Carboyls, 3-Nitrotyrosine, 8-OHG)on surgery
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. Hatzikosta General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ioannina
- Responsible party
- Principal investigator, E.Tsimoyiannis, G. Hatzikosta General Hospital
- Investigators
- George Pappas-Gogos, MD, Principal investigator, G. Hatzikosta General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470586
- Sponsor's protocol ID
- GH-1948-08
- Status last verified
- Nov 2011
- First submitted
- 5 Nov 2011
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01470586
- Acronym / sponsor ID
- GH-1948-08
- Conditions
- Colorectal Cancer, Colon Rectal Resection, Oxidative Stress
- Keywords
- Colorectal cancer, Surgical resection, Oxidative Stress Markers, Controls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- G. Hatzikosta General HospitalUniversity, hospital or other
- Collaborators
- University of Ioannina
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for RNA peroxidation)in patients with colorectal cancer undergo surgical treatment (preoperatively during the intervention and postoperatively) and controls.
Detailed description
Study of the impact of surgery on Lipid peroxidation, Protein peroxidation, damage by nitrogens, and RNA peroxidation, in patients undergo surgical resection for colorectal cancer and compared with controls, and validation of the responsiveness of oxidative stress markers on surgery
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery for colorectal cancer | Other | Procedure: Surgery for colorectal cancerColorectal cancer patients |
| Controls | No intervention | –Controls |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with colorectal cancer
- Controls
Key exclusion criteria (8 listed)
- ASA>3
- Metastatic Disease
- Acute bowel obstruction
- Acute bowel perforation
- BMI<30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for colorectal cancerAlso: Open or Laparoscopic resection for colorectal cancer, Low anterior resection, Sigmoidectomy, Left colectomySurgical resection of colorectal cancer | Procedure or surgery | Surgery for colorectal cancer |
Primary outcome
Comparison of Oxidative stress markers in patients with colorectal cancer and controls
Time frame: up to 2 years
Oxidative stress markers variation (8-PGF2α, Protein Carboyls, 3-Nitrotyrosine, 8-OHG) during and after surgery for colorectal cancer, and compare with controls
1 secondary outcome
Validation of oxidative stress markers in patients with colorectal cancer undergo surgical resection
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Pappas-Gogos, MD principal investigator
G. Hatzikosta General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery for colorectal cancer in people with Colorectal Cancer and Colon Rectal Resection, run by G. Hatzikosta General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Oxidative stress markers in patients with colorectal cancer and controls (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2011.